Siemens Healthcare Diagnostics, Inc. recalls syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laborat…

Recall date

August 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1195-2019

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.

Why it was recalled

Software Issues.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features.